Distance, diameter and area determining device

ABSTRACT

The invention describes a novel implementation of ultrasound or OCT technology to approximate the dimensions of fluid-filled structures (when using ultrasound technology) or other structures (when using OCT technology). The invention in a preferred embodiment is an elongated member such as a catheter that uses ultrasound or OCT technology to approximate the dimensions of a structure into which the catheter has been placed. In a preferred embodiment, the catheter includes multiple ultrasound transducers arranged in an annular or circumferential configuration on, embedded into or within the body of the elongated member so that distance measurements can be obtained between the elongated member and the wall of the immediately facing structure (e.g., a fluid-filled lumen). Utilizing these measurements, the present invention approximates for the physician the shape and size of the structure into which the elongated member is placed. The invention also includes a method for producing three-dimensional images from two-dimensional images.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to methods and medical devicesthat gather information about vessels, structures or devices in a bodyand more particularly to methods and medical devices for measuringdimensions of such vessels, structures or devices and calculatecross-sectional areas of such vessels, structures or devices.

2. Description of Related Art

Within the field of interventional cardiology, the utilization ofcoronary drug-eluting stents has significantly reduced stent failure andthe need for revascularization. Recent imaging studies have illustratedthat the predominate cause of residual stent failure is stentunderexpansion and lesion edge problems such as undersizing the lengthof the stent needed to appropriately cover the lesion. The limitationsof today's angiogram often do not allow the physician to adequatelyassess the lesion prior to stent placement or determine the degree ofexpansion of the deployed stent. This is a problem in need of asolution.

Current imaging catheters utilize ultrasound or optical technologies toprovide a cross-section image that is then interpreted by the physicianto determine, among other characteristics, the dimensions of the lumensurrounding the catheter. For example,

Intravascular Ultrasound (IVUS) is commonly used in interventionaldiagnostic procedures to image blood vessels to locate and characterizeatherosclerosis and other vessel diseases and defects. In use, aguidewire is placed in a vessel of interest. Then, an IVUS catheter isthreaded over the guidewire and ultrasonic signals are sent from thecatheter, bounced off the tissue, received by the catheter and passedfrom the catheter to a system. These ultrasound echoes are processed bythe system to produce images of the vessel and its physiology.

Optical Coherence Tomography (OCT) systems are also used ininterventional diagnostic procedures to image blood vessels to locateand characterize atherosclerosis and other vessel diseases and defects.In use, again a guidewire is placed in a vessel of interest. Then, anOCT catheter is threaded over the guidewire and light signals are sentfrom the catheter, bounced off the tissue, received by the catheter andpassed from the catheter to a system. These light echoes are processedby the system to produce images of the vessel and its physiology.

These IVUS and OCT images and the information about the vessel,including vessel dimensions, is considerably more detailed than theinformation that is obtainable from traditional angiography images thatwhich shows only a two-dimensional shadow of the vessel lumen. Examplesof some of the information provided by IVUS or OCT systems include:determining a diameter of a vessel to be used in determining the correctdiameter or a stent to be placed; determining the length of aphysiological problem such as the presence of atherosclerotic materialso that the correct length of a stent to be placed can be determined todilate the stenosis; verifying that a stent, once placed, is wellapposed against a vessel wall to minimize thrombosis and optimize drugdelivery (in the case of a drug eluting stent); verifying that after astent has been place, the diameter and luminal cross-section area of thestented vessel are adequate; and identifying an exact location ofside-branch vessels to aid in stent placement or therapy delivery.

But, although current IVUS and OCT systems provide additional and moredetailed information compared to angiograms, these IVUS and OCT systemsintroduce significant additional time, cost and complexity intominimally-invasive procedures. Further, the images produces by IVUS andOCT systems often are subject to interpretation of the physician. Thus,there is a need for an improved way to get information about a vessel orstructure, particularly information about the diameter of a vessel orstructure.

SUMMARY OF THE INVENTION

The invention describes a novel implementation of ultrasound or OCTtechnology to approximate the dimensions of fluid-filled structures(when using ultrasound technology) or other structures (when using OCTtechnology). The invention in a preferred embodiment is an elongatedmember such as a catheter that uses ultrasound or OCT technology toapproximate the dimensions of a structure into which the catheter hasbeen placed. In a preferred embodiment, the catheter includes multipleultrasound transducers arranged in an annular or circumferentialconfiguration on, embedded into or within the body of the elongatedmember so that distance measurements can be obtained between theelongated member and the wall of the immediately facing structure (e.g.,a fluid-filled lumen). Utilizing these measurements, the presentinvention approximates for the physician the shape and size of thestructure into which the elongated member is placed. The invention alsoincludes a method for producing three-dimensional images fromtwo-dimensional images.

The disclosed device, as used in accordance with the methods of theinvention, ensures a simpler way of calculating cross-sectionaldimensions and creating three-dimensional maps than prior art devicesand techniques.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described hereafter in detail with particularreference to the drawings. Throughout this description, like elements,in whatever embodiment described, refer to common elements whereverreferred to and reference by the same reference number. Thecharacteristics, attributes, functions, interrelations ascribed to aparticular element in one location apply to that element when referredto by the same reference number in another location unless specificallystated otherwise. In addition, the exact dimensions and dimensionalproportions to conform to specific force, weight, strength and similarrequirements will be within the skill of the art after the followingdescription has been read and understood.

All figures and drawn for ease of explanation of the basic teachings ofthe present invention only; the extensions of the figures with respectto number, position, relationship and dimensions of the parts to formexamples of the various embodiments will be explained or will be withinthe skill of the art after the following description has been read andunderstood.

FIG. 1 is a side schematic view of a preferred embodiment of thecatheter of the present invention.

FIG. 2 is an end view of an alternate embodiment of the catheter of thepresent invention.

FIG. 3A, FIG. 3B and FIG. 3C are end views of the transducer arrays ofalternate embodiments of the catheter of the present invention.

FIG. 4A and FIG. 4B are perspective views of a switch and a single arrayof transducers of an alternate embodiment of the catheter of the presentinvention.

FIG. 5 is a perspective view of the catheter of the present invention inuse in a vessel.

FIG. 6 is an end schematic view of the catheter of an embodiment of thepresent invention used to determine the cross-sectional area of astructure.

FIG. 7 is a side schematic view of an embodiment of the catheter of thepresent invention having an angioplasty balloon.

FIG. 8 is a side schematic view of an embodiment of the catheter of thepresent invention having a stent deployment balloon and a stent.

FIG. 9 is a side schematic view of a rapid exchange embodiment of thecatheter of the present invention.

FIG. 10 is a perspective phantom view of three-dimensional map madeaccording to the present invention.

FIG. 11 is a perspective phantom view of another three-dimensional mapmade according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In order that the invention may be clearly understood and readilycarried into effect, preferred embodiments of the invention will now bedescribed with reference to the accompanying drawings. The descriptionof these embodiments is given by way of example only and not to limitthe invention. The medical device of the present invention, in all ofits embodiments, is shown in the drawings generally labeled 10. Apreferred embodiment of the present invention being described herein isa catheter. But, the invention applies to many other devices whereknowing the dimensions around the medical device 10 is desirable.

As mentioned above, although a preferred embodiment of the presentinvention is a catheter, the invention applies to many other deviceswhere it is desirable to know the cross-sectional dimensions the spacesurrounding the medical device 10. Examples of such medical devices 10include, but are not limited to, conventional intravascular ultrasound(IVUS), optical coherence tomography (OCT) and photoacoustic imagingsystems, image guided therapeutic devices or therapeutic deliverydevices, diagnostic delivery devices, Forward-Looking IVUS (FLIVUS),intracardiac echocardiography (ICE), forward looking ICE, opticallight-based imaging (e.g., endoscopes), pressure sensing wires, highintensity focused ultrasound (HIFU), radiofrequency, thermal imaging orthermography, electrical impedance tomography, elastography, orthopedicand spinal imaging and neurological imaging.

As shown in FIG. 1, the medical device 10 of the present inventionincludes a body member 12 having a proximal end 14 and a distal end 16.The medical device 10 includes a plurality of transducers 18. In apreferred embodiment, the medical device 10 also includes an elongatedtip 20 having a proximal end 22 and a distal end 24. The medical device10 includes a proximal connector 26. In an embodiment of the invention,the medical device 10 is part of a system 28 that includes a distalconnector 30, electrical conductors 32, a data acquisition unit 34 and acomputer 36.

In a preferred embodiment of the medical device 10 shown in FIGS. 1-5,the body member 12 is tubular and has a central lumen 38. In a preferredembodiment of the medical device 10, the body member 12 has a diameterof about 650 μm. This dimension is illustrative and not intended to belimiting. In embodiments of the medical device 10, the diameter of themedical device 10 will depend on the type of device that medical device10 is and where the medical device 10 will be used, as is wellunderstood in the art.

The proximal end 14 of the body member 12 is attached to the proximalconnector 26. In the embodiment of medical device 10 that includes anelongated tip 20, proximal end 22 of the elongated tip 20 is attached tothe distal end 16 of the body member 12. The elongated tip 20, whereemployed, allows the catheter 20 to be moved along a rapid exchangedevice, were employed as described below, adds flexibility to the distalend of the medical device 10 to allow easier maneuvering of the medicaldevice 10, particularly in vessels, and allows the transducers 18, incertain embodiments, to be more precisely located in the vessel or otherstructure where the medical device 10 is placed.

The body member 12 and elongated tip 20 are made of resilient flexiblebiocompatible material such as is common for IVUS catheters as is wellunderstood by those skilled in the art. Medical device 10 is preferablytubular with a central lumen 38 but may also not have a central lumen38. Further, medical device 10 may have one or more lumens in additionto central lumen 38. Preferably, the outer diameter of the body member12 and elongated tip 20, if present, is substantially constant along itslength. But, neither the body member 12 nor elongated tip 20 is requiredto have a substantially constant diameter.

The transducers 18 in embodiments of the medical device 10 usingultrasound are preferably conventional piezoelectric transducers such asare typically used on IVUS catheters. These piezoelectric transducersare built from piezoelectric ceramic material and covered by one or morematching layers that are typically thin layers of epoxy composites orpolymers. In addition, other transducer technologies may be used tocreate transducers 18 including, but not limited to, PMUT (PiezoelectricMicromachined Ultrasonic Transducer), CMUT (Capacitive MicromachinedUltrasonic Transducer) and photoacoustic technologies. The medicaldevice 10 of the present invention may be of the rotational type orsolid state (non-rotational type) such as are commonly in use inconnection with IVUS imaging systems.

Further, the operating frequency for the ultrasound transducers 18 istypically in the range of from about 8 to about 50 MHz, depending on thedimensions and characteristics of the transducer. Generally, higherfrequency of operation provides better resolution and a smaller medicaldevice 10. But, the price for this higher resolution and smallercatheter size is a reduced depth of penetration into the tissue ofinterest and increased echoes from the blood itself (making the imagemore difficult to interpret). Lower frequency of operation is moresuitable for imaging in larger vessels or within structures such as thechambers of the heart. Although specific frequency ranges have beengiven, this range is illustrative and not limiting. The ultrasonictransducers 18 may produce and receive any frequency that leaves thetransducer 18, impinges on some structure or material of interest and isreflected back to and picked up by the transducer 18.

The medical device 10 may, in some embodiments, use optical coherencetomography (OCT) transducers 18. These OCT transducers produce light inthe near infrared range that leaves the transducer 18, impinges on somestructure or material of interest and is reflected back to and picked upby the transducer 18. In some embodiments of these OCT transducers 18,the light is produced by a laser or other coherent light source outsideof the medical device 10 and passed to the medical device 10 via fiberoptic strands through the proximal connector 26 and ultimately to thelocation of the transducers 18 near the distal end 16 of the body member12. In other embodiments of the medical device 10 that uses OCTtransducers 18, the light needed for the transducers 18 is produced onthe medical device 10 itself (e.g., at or near the proximal end 14 ofthe body member 12 by, for example, laser diodes) or at the site of thetransducers 18 themselves as, for example, by laser diodes. Also, thesetransducers 18 have been described as having been of the OCT type. But,any transducers 18 that use coherent light or electromagnetic radiationmay be used.

Regardless of whether the transducers are of the ultrasound or OCT type,the transducers 18 may be located on the outer surface 40 of the bodymember 12, within the material of the body member 12, on the surface ofthe central lumen 38 or within the central lumen 38. In thoseembodiments where the transducers 18 are not located on the outersurface 40 of the body member 12, the material of the body member 12must be transparent to the ultrasonic waves or light emitted from orreturning to the transducers 18 or the ultrasonic waves or light emittedfrom or returning to the transducers 18 may pass through windows in thematerial of the body member 12.

In the medical device 10 of the invention, two or more transducers 18are arranged in a single annular or circumferential ring around orwithin the body member 12 (FIG. 4A) or can be an array of multipleannular or circumferential rings located one behind the other (FIG. 4B).Where the medical device 10 includes an array of transducers 18 such asis shown in FIG. 4B, the transducers 18 in one annular orcircumferential group are preferably, although not required to be,staggered with respect to the transducers 18 in the annular orcircumferential group located either more proximal or distal to it.Further, although arrays of two annular or circumferential groups oftransducers 18 are shown, any number of annular or circumferentialgroups of transducers 18 may be used.

As stated, the circumferential arrays of transducers 18 are axiallyseparated along the body member 12. In one configuration of thecircumferential arrays of transducers 18, the transducers 18 in onearray are aligned with the transducers 18 in the adjacent array alongthe elongated axis of the body member 12. In another, preferredembodiment of the medical device 10 shown in FIG. 4B, the transducers 18in one array are staggered with respect to the transducers 18 in theadjacent array. “Staggered” means that the transducers 18 in one arrayare not aligned with the transducers 18 in the adjacent array along theaxis of the body member 12.

In the preferred embodiment of the medical device 10 of FIG. 4B, thetransducers 18 in one array overlap with the transducers 18 in theadjacent array so that a very compact configuration of transducers 18 isproduced. For example, by way of illustration, the medical device 10could have two arrays of transducers 18 where the transducers 18 arestaggered with respect to the transducers 18 of the adjacent array (FIG.4B) and the centers of the transducers 18 of one array are spaced fromthe centers of the transducers 18 of the other array by a distance, forexample, of about 250 μm. This dimension is illustrative and notintended to be limiting. Further, although the preferred embodiment ofthe medical device 10 has the transducers 18 of one array overlappingwith the transducers 18 of the adjacent array, these transducers 18 arenot required to be overlapping.

This embodiment of the medical device 10 where one circumferential arrayof transducers 18 is off-set from and overlapping or interlaced with theadjacent array of transducers 18 allows each transducer 18 to havesufficient surface area to be effective because the distance between thecenters of each transducer 18 is minimized. As a result, the staggeringand in some cases the interlacing of the transducers 18 allows all thetransducers 18 to fit within a small circumference as required when thetransducers 18 are utilized on small medical devices 10 such as a 0.035″or 0.018″ wire or even a 0.014″ wire such as would be used in coronaryguidewire such as much pass through the lumen tube of an angioplastycatheter which is approximately 650 um in size.

The surface shape of the transducers 18 can be circles, ovals, squares,rectangles, triangles, wedges, or similar shapes. The distance betweencenters of each ultrasound transducer 18 can be as large as 1-2 mmwithout being significant to vascular measurements although distancesless than 1 mm are preferable and even more preferable is less than 500um. At center-spacing distances of 500 um or less, the distancemeasurements produced by the transducers 18 will not be meaningfullyaltered by the fact that the transducers 18 in adjacent arrays oftransducers 18 are not circumferentially aligned.

As shown in FIG. 6, each of the transducers 18, when energized, emits anultrasonic wave or light that is directed away from the transducer 18and thus from the body member 12. As shown in FIG. 2, because thetransducers 18 are located in an annular or circumferential fashionaround the body member 12, the ultrasonic waves or light they emit aredirected away from the body member 12 in non-parallel paths. Thetransducers 18 may be energized to emit ultrasonic waves or lightsimultaneously or may be energized selectively (e.g., sequentiallyaround the circumference of the body member 12 or in any other selectivefashion).

The transducers 18 can be individually connected to electricalconductors 32 to connect the transducers 18 to the proximal connector26. In certain embodiments, each transducer 18 needs an electricalpulses to energize the transducer 18 and the ability to deliver receivedecho signals from the transducer 18 electrically to a computer 36 orPatient Interface Module (PIM) 44 to be analyzed (during the intervalsbetween transmit pulses). Where a PIM 44 is used, the PIM is locatedalong the path between the medical device 10 and computer 36 and mayinclude the distal connector 30. The computer 36 or PIM 44 controls theelectrical or optical pulses sent to the transducer 18, processes,amplifies, filters or aggregates the data, interprets the signal comingback from the transducer 18 after the transducer 18 picks up thereceived echoes from the emitted pulses, produces images, makescalculations including calculations of dimensions and performsco-registration of images, data and calculations produced by thecomputer 36 with other images, data and calculations.

The electrical conductors 32 in certain embodiments run from thetransducers 18 to the proximal connector 26 and may run within thematerial of the body member 12 or along its outer surface 40 or along orwithin the central lumen 38 to conduct the electrical excitationprovided to the proximal connector 26 to the transducer 18 and returnthe signal from the transducer 18 thereafter to the proximal connector26. Electrical conductors 32 also carry signals from the transducers 18to the computer 36 or PIM 44. The electrical conductors 32 may be wiresincluding twisted pair wire, coaxial cable, fiber optics, wave guidesand other wire media as is well understood in the art.

In other embodiments of the medical device 10, particularly thoseembodiments using OCT technology, optical fibers carry energy to thetransducers 18 and signals from the transducers 18 to the computer 36 orPIM 44 or both. In a variant embodiment applicable to both ultrasoundand OCT systems, electrical energy may be carried to the transducers 18via electrical conductors 32 and the signal of the received echoes sentback from the transducers 18 to the computer 36 or PIM 44 via opticalfibers.

Further, although in some embodiments of the medical device 10, thetransducers 18 send their signals to the computer 36 or PIM 44 throughelectrical conductors 32 or optical fibers, in other embodiments, thetransducers 18 communicate their signals to the computer 36 or PIM 44through wireless communication means well known to those skilled in theart including but not limited to acoustic, RF and infrared technology.

Alternately, as shown in FIG. 5, the transducers 18 can be connected toan electrical switch 46 located between the electrical conductors 32 andthe transducers 18. The electrical switch 46 reduces the number ofnecessary electrical conductors 32 by having fewer lines travel from theproximal connector 26 to the switch 46 and then having the electricalenergy carrying ability of the few line expanded through the switch toreach the multitude of transducers 18. Further, additional electricalconductors 32 or optical fibers can be added to control the electricalswitch 46. In a preferred embodiment of switch 46, switch 46 is amultiplexer such as is well understood in the art. The use of amultiplexer reduces the number of electrical conductors 32 or opticalfibers passing from the proximal connector 26 through the body member 12to the transducers 18 and in some cases, provides additional controlfunctions.

Preferably, four (FIG. 3A) to 12 transducers 18 are used formeasurements in a medical device 10. More preferably, six (FIG. 3C) toten transducers 18 will be utilized (FIG. 3B showing eight transducers18). Where the medical device 10 is a coronary catheter, because of theneed to keep the medical device 10 small in order to fit into the smallcoronary arteries, each transducer 18 will preferably have an area ofless than about 1 mm². The number of transducers 18, as well as thedimensions given, are for illustration purposes only and not intended tobe limiting. Any number of two or more transducers 18 as well as anypractical dimensions for the transducers 18 may be used as technologyallows and as desired by those skilled in the art.

Where the medical device 10 is part of a system 28, in addition to themedical device 10 described above, the system 28 will further includethe computer 36 or PIM 44 or both (instead of just having the medicaldevice 10 connected to the computer 36 or PIM 44). Where the medicaldevice 10 is part of a system 28, a distal connector 30 mates with theproximal connector 26, as is well understood in the art, to connect themedical device 10 to the rest of the system 28. Electrical conductors 32carry the control signals or energy or both to the distal connector 30where the control signals, energy or both are passed to the proximalconnector 26 to be used by the medical device 10.

The system 28 also preferably includes a data acquisition unit 34 thatmay be part of or separate from the computer 36 or PIM 44. The dataacquisition unit 34 converts the analog data produced by the transducers18 into digital data that can be processed by the computer 36 or PIM 44.As mentioned, the data acquisition unit 34 may be part of or separatefrom either the computer 36 of PIM 44. In addition, the data acquisitionunit 34 may be part of the medical device 10 itself or may be located inthe distal connector 30 or elsewhere along the path from the distalconnector 30 to the computer 34 or PIM 44.

In an embodiment of the medical device 10 shown in FIG. 7, anangioplasty balloon 48 is placed on or around the body member 12 as iswell understood in the art. In this embodiment, the transducers 18 arepreferably placed distal to the angioplasty balloon 48. In anotherembodiment of the medical device 10 shown in FIG. 8, a stent deliveryballoon and stent assembly 50 is placed on or around the body member 12as is well understood in the art. In this embodiment, the stent deliveryballoon and stent assembly 50 includes a stent delivery balloon 52 and astent 54. The transducers 18 are also preferably placed distal to thestent delivery balloon and stent assembly 50. In either of theseembodiments, the medical device 10 includes a duct 56 that travels alongthe length of the body member 12 from the respective balloons and endsin an inflation port 58. Balloon 48 or the balloon of the stent deliveryballoon and stent assembly 50 may be selectively inflated and deflatedvia the inflation port 58.

In an embodiment of the medical device 10 shown in FIG. 9, the medicaldevice 10 is a rapid-exchange catheter. Accordingly, the medical device10 further includes a guide wire exit port 60 located on or near thedistal end 24 of the elongated tip 20 in order to aid in directing themedical device 10 through a vessel. Of course, the medical device 10 maybe an “over-the-wire” device. In this embodiment of the medical device10, a guidewire passes through the medical device 10 through the centrallumen 38 from the proximal connector 30 to the distal end 16 of the bodymember 12 or distal end 24 of the elongated tip 20 if an elongated tipis used. In order for the guidewire to pass entirely through the medicaldevice 10, the central lumen 38 must also pass through the array orarrays of transducers 18 as well as the switch 46 and elongated tip 20,if either is present.

In embodiments of the present invention involving the system 28, thesystem 28 may also include a patient interface module PIM 44 thatfacilitates communications between the medical device 10 and theremaining aspects of the system 28. In some embodiments of the system28, the PIM 44 performs some of the functions of the computer 36including, but not limited to, amplification, filtering, or aggregatingof the data or any combination of these. Further, the PIM 44 may alsosupply high and low voltage AC or DC power or light to the body member12 including for powering the transducers 18.

In use, the medical device 10 described above, is placed in a desiredlocation, for example, by advancing the medical device 10 up the femoralartery to a desired location in the aorta. Because of the uniquelocation of each of the transducers 18 on the outer surface 40 of thebody member 12, one the medical device 10 is in a desired location, eachtransducer 18 is “aimed” at a different location and thus will “see”different structure (FIG. 2). With the medical device 10 in the desiredlocation, the transducers 18 are energized so that either an ultrasonicor light wave produced by the transducers 18 leave the transducers 18 toimpinge on the surrounding structure (FIG. 6). The ultrasound or lightwaves reflect off the surrounding structure (which could be tissue,blood or other fluid, devices, bone, etc.) at different depths andreturn to the transducers 18 where they are picked up by one or moretransducer 18 (FIG. 6). The signal detected by each transducer 18 issent to the computer 36 or PIM 44 to be processed.

In particular, the signal is processed to calculate the distance fromeach transducer to the nearest structure (e.g., the wall of the vesselin which the medical device 10 is placed). The distance is calculatedusing time-of-flight techniques associated with IVUS and OCT systemssuch as is well understood in the art.

Because each transducer 18 is uniquely aimed circumferentially aroundthe medical device 10 (FIGS. 2 and 3A-3C), each transducer 18 willproduce a signal representative of the distance from that transducer 18to the structure nearest that transducer 18. For example as shown inFIG. 10, the medical device 10 has six transducers in each array oftransducers 18. Each transducer 18 sends and receives a signal toproduce respective distances D₁-D₆ in one array and distances D₇-D₁₂ inan adjacent array. When all the distances from each of the transducers18 to their respective nearest structures are received, and because thediameter of the body member 12 where the transducers 18 are located isknown, the computer 36 or PIM 44 can calculate the diameter of thecavity around the transducers 18 at any location radially from thetransducers 18. This is done by taking the calculated distance fromtransducers 18 arranged on opposite sides of the body member 12 to theirrespective nearest structure (e.g., D₁ and D₄, D₂ and D₅, D₃ and D₆) andadding the diameter of the medical device 10 at the transducers 18 todetermine the axial distance from one “wall” of the structure facing onetransducer 18 to the “wall” of the structure facing the transducer 18directly opposite the first transducer 18. By calculating such distancesof respective pairs of transducers 18 (e.g., D₁ and D₄, D₂ and D₅, D₃and D₆), the radial distance or diameter from one “wall” to the opposite“wall” along an axis passing through the paired transducers 18 can bedetermined. When several such distances are calculated and plottedradially around the medical device 10, a map of the cross-section of thestructure (e.g., blood vessel, heart chamber, bladder) can bedetermined.

Note that this map is a two-dimensional map. But, a three-dimensionalmap may also be produced by the medical device 10. This may beaccomplished two ways. First, in embodiments of the medical device 10where there is more than one array of transducers (FIG. 4B), each arraywill produce its own two-dimensional cross-sectional map. For example,in FIG. 10 two maps are made, the first map made up of distances D₁-D₆and connecting segments M₁-M₆ corresponding to a first array oftransducers 18 and a second map made up of distances D₇-D₁₂ andconnecting segments M₇-M₁₂, respectively. Because each array oftransducers 18 is spaced from its neighbor array of transducers 18, theresulting two-dimensional cross-sectional maps will represent differentcross-sections of the underlying structure (e.g., cross-sectionsseparated by the spacing between each of the circumferential arrays).Combining these multiple two-dimensional maps produces athree-dimensional structure (FIG. 10).

Another way of producing a three-dimensional map is to move the medicaldevice 10 axially forward or backwards while taking measurements.Preferably, such forward or backward axial movement is done in acontrolled and measured way. By knowing the speed and direction of thepullback, the location of the respective distance measurements can beplotted to define a three-dimensional structure. For example, if amedical device 10 is in a blood vessel, for example during a veinogram,and is pulled back at a controlled rate while taking measurements of thedistance from each of the transducers 18 to the wall of the blood vesseldirectly facing the transducer 18, a three-dimensional map of the bloodvessel is produced (FIG. 11).

In the example of FIG. 11, each array of transducers 18 will produce itsown two-dimensional cross-sectional map. In the example of FIG. 11 threemaps are made. The first map is made up of distances D₁₃-D₁₈ andconnecting segments M₁₃-M₁₈ corresponding to a first array oftransducers 18. A second map is also made up of distances D₁₉-D₂₄ andconnecting segments M₁₉-M₂₄, respectively. This second map can be madeby either a second array of transducers 18 as described above inconnection with the maps of FIG. 10 or may be made by making a first mapby an array of transducers 18 and then moving that same array oftransducers axially to produce the second map. In addition, acombination of both approaches to creating maps can be done so that eacharray of transducers 18 produces a map at a particular axial location ofthe medical device 10 and each array produces additional maps as themedical device 10 is being moved axially. Because each array oftransducers 18 is spaced from its neighbor array of transducers 18, theresulting two-dimensional cross-sectional maps will represent differentcross-sections of the underlying structure (e.g., cross-sectionsseparated by the spacing between each of the circumferential arrays).Combining these multiple two-dimensional maps, however produced,produces a three-dimensional structure (FIG. 11).

The two or three-dimensional maps described above may be co-registeredto data, figures, physiological measurements, images such as x-ray,fluoroscopy, IVUS, OCT, CT, MRI and other previous or currently acquiredimages or information according to known co-registration techniques.

Further, with the cross-sectional maps formed as described above, thecross-sectional area can be determined. This cross-sectional area isdetermined by taking the distance lines produced by the transducers 18to calculated diameters, which distance lines are adjacent to each othercircumferentially around the medical device 10, generating a lineconnecting the adjacent distance lines to create a two-dimensionalclosed substantially “pie piece” shape, calculating the area of thatshape and then adding together the areas of all the shapes to get thetotal area of the structure around the medical device 10. Techniques forgenerating the lines connecting adjacent diameters to createtwo-dimensional closed shapes include, but are not limited to, formingstraight lines, arcs of a circle, curves and splines, such as Basissplines or B-splines, and may take into consideration information fromother two-dimensional cross-sectional diameters or distances from thetransducers 18 to the closest tissue or structure of interest determinedfrom other arrays of transducers 18 on the medical device 10 or fromtwo-dimensional diameters determined from moving the medical device 10axially as described above.

The transducers 18 of one or more arrays may be energized simultaneouslyso that a “snap shot” image is produced. Where the transducers 18 areenergized simultaneously, the medical device 10 must be configured to beable to pass the signals produced by the various transducers 18 byreceiving their respective echoes back to the computer 36 or PIM 44 tobe processed. The transducers 18 of one or more arrays may also beenergized in a predetermined sequence to reduce the amount ofinformation necessary to be passed back to the computer 36 or PIM 44 atany given time. This sequential energizing of transducers 18 may bedesirable when using a multiplexer switch 46 as described above.

In the embodiments of the medical device 10 that include an angioplastyballoon 48, the medical device 10 is located in a vessel such as acoronary artery so that the angioplasty balloon 48 is at a desiredlocation. Fluid is passed into the inflation port 58 where it travelsthrough the duct 56 to inflate the angioplasty balloon 48 as is wellunderstood in the art. The transducers 18 may be fired before, duringand after activation of the angioplasty balloon 48 to assist incorrectly locating the angioplasty balloon 48, ensuring that theangioplasty balloon is inflating correctly and is applying the desiredtherapy (e.g., the vessel diameter is increasing) and confirming thatthe angioplasty procedure was successful after the angioplasty balloon48 is deflated but before the medical device 10 is removed. Thetransducers 18 are operated and the diameter of the vessel determined asdescribed above.

In embodiments of the medical device 10 that include a stent deliveryballoon and stent assembly 50, again the medical device 10 is located ina vessel such as a coronary artery so that the stent deployment balloon52 of the stent delivery balloon and stent assembly 50 is at a desiredlocation. Fluid is passed into the inflation port 58 where it travelsthrough the duct 56 to inflate the stent deployment balloon 52 as iswell understood in the art. Again, the transducers 18 are fired, asdescribed above, before, during and after activation of the stentdeployment balloon 52 to assist in correctly locating the stent 54,ensuring that the stent deployment balloon 52 is inflating correctly andis applying the desired therapy (e.g., the vessel diameter is increasingand the stent 54 is deploying) and confirming that the stent 54 wassuccessfully and fully deployed after the stent deployment balloon 52 isdeflated but before the medical device 10 is removed. The transducers 18are operated and the diameter of the vessel determined as describedabove. This embodiment of the medical device 10 confirms that the stent54 is fully deployed and that the correct stent 54 is used. In theembodiments using either an angioplasty balloon 48 or a stent deliveryballoon and stent assembly 50, the preferred number of transducers 18placed circumferentially around the body member 12 is from six to eightalthough fewer or more transducers 18 may be used depending on where themedical device 10 is used, the frequency of the emitted ultrasound orlight signals, among the possible considerations.

The present invention has applicability wherever it is desirable to knowthe cross-sectional dimensions the space surrounding the device.Illustrative examples of these applications include, but are not limitedto, diagnosing or treating non-thrombotic venous disease, coronarystable angina, placing or retrieving inferior vena cava (IVC) filters,replacing or repairing heart valves, placing peripheral drug elutingballoons (DEB),

Throughout this description, mention has been made of placing themedical device 10 in vessels. Vessel, as used herein, means any fluidfilled structure or structure surround by fluid within a living body or,where ultrasound is not use, any structure that may be imaged andincludes both natural and man-made structures. Examples of such vesselsinclude, but are not limited to, organs including the heart, arteries,veins, liver, kidneys, gall bladder, pancreas, lungs, breasts; ducts;intestines; nervous system structures including the brain, dural sac,spinal cord and peripheral nerves; the urinary tract; rectum; vagina; aswell as valves within the blood or other systems of the body. Inaddition to the previously listed natural structures, the medical device10 may be used as described herein to calculate dimensions, image orotherwise take data on such man-made structures as, without limitation,heart valves, stents, shunts, filters and other devices positionedwithin the body, for example, a guide wire or guide catheter.

While the above description contains many specifics, these should not beconstrued as limitations on the scope of the invention, but rather asexamples of preferred embodiments thereof. As a result, the descriptioncontained herein is intended to be illustrative and not exhaustive. Manyvariations and alternatives of the described technique and method willoccur to one of ordinary skill in this art. Further, the medical device10 has been described in connection with producing maps of the distancefrom the transducers 18 to the tissue of structure opposite thetransducers 18 or the area around the transducers 18. But, the medicaldevice 10 may also be used to produce images such as intravascularultrasound (IVUS) or OCT images as is well understood in the art.

Variations in form of the component pieces described and shown in thedrawings may be made as will occur to those skilled in the art. Further,although certain embodiments of a medical device 10 have been described,it is also within the scope of the invention to add other additionalcomponents or to remove certain components such as the elongated tip 20,multiple arrays of transducers 18, switches 46 or proximal connectors26. Also, variations in the shape or relative dimensions of all of thevarious components of the medical device 10 or system 28 will occur tothose skilled in the art and still be within the scope of the invention.

All these alternatives and variation are intended to be included withinthe scope of the attached claims. Those familiar with the art mayrecognize other equivalents to the specific embodiments described hereinwhich equivalents are also intended to be encompasses by the claimsattached hereto. As a result, while the above description contains manyspecifics, these should not be construed as limitations on the scope ofthe invention but rather as examples of different embodiment thereof.

1. A medical device comprising: an elongated body member having aproximal end, a distal end, an outer surface and an elongated axis; aplurality of arrays of transducers, each array having a plurality oftransducers located circumferentially on or near the outer surface ofthe body member, each transducer emitting signals away from therespective transducer and receiving reflected signal, each transducerpassing received signal to the proximal end of the body member, eacharray of transducers spaced along the body member from an adjacent arrayof transducers.
 2. The medical device of claim 1 wherein at least onearray of transducers overlaps with an adjacent array of transducers. 3.The medical device of claim 2 wherein the transducers of one array oftransducers are staggered with the transducers in the adjacent arrayalong the elongated axis of the body member.
 4. The medical device ofclaim 1 wherein the transducers of one array of transducers arestaggered with the transducers in the adjacent array along the elongatedaxis of the body member.
 5. The medical device of claim 1 furthercomprising an elongated tip having a proximal end and a distal end, theproximal end of the elongated tip being connected to the distal end ofthe body member.
 6. The medical device of claim 5 further comprising aguide wire exit port located on the elongated tip.
 7. The medical deviceof claim 1 wherein the body member is tubular and has a central lumen.8. The medical device of claim 7 wherein the body member has more thanone lumen in addition to the central lumen
 9. The medical device ofclaim 1 wherein the medical device is a rotational medical device. 10.The medical device of claim 1 wherein the medical device is a solidstate medical device.
 11. The medical device of claim 1 wherein thetransducers are chosen from the group consisting of piezoelectrictransducers, PMUT (Piezoelectric Micromachined Ultrasonic Transducers),CMUT (Capacitive Micromachined Ultrasonic Transducers) and photoacoustictransducers.
 12. The medical device of claim 1 wherein the transducersare optical coherence tomography (OCT) transducers.
 13. A medical systemcomprising: a medical device comprising: an elongated body member havinga proximal end, a distal end, an outer surface and an elongated axis; aplurality of arrays of transducers, each array having a plurality oftransducers located circumferentially on or near the outer surface ofthe body member, each transducer emitting signals away from therespective transducer and receiving reflected signal, each transducerpassing received signal to the proximal end of the body member, eacharray of transducers spaced along the body member from an adjacent arrayof transducers, wherein the transducers produce a signal; a computerconnected to the medical device to process signals from the medicaldevice.
 14. The medical device of claim 1 wherein at least one array oftransducers overlaps with an adjacent array of transducers.
 15. Themedical device of claim 14 wherein the transducers of one array oftransducers are staggered with the transducers in the adjacent arrayalong the elongated axis of the body member.
 16. The medical device ofclaim 14 wherein the transducers of one array of transducers arestaggered with the transducers in the adjacent array along the elongatedaxis of the body member.
 17. The system of claim 14 wherein theprocessing of signals performed by the computer includes processingselected from the group consisting of controlling the transducers,processing data, interpreting the signal coming from the transducers,calculating the dimensions from the medical device to the tissue orstructure around the medical device, calculating the area around themedical device to the tissue or structure around the medical device andperforming co-registration of images, data and calculations produced bythe computer with other images, data and calculations.
 18. The system ofclaim 14 further comprising a Patient Interface Module (PIM) locatedalong the path between the medical device and computer.
 19. A methodsystem for determining physiological measurements around a medicaldevice comprising: providing a medical device comprising: an elongatedbody member having a proximal end, a distal end, an outer surface and anelongated axis; a plurality of arrays of transducers, each array havinga plurality of transducers located circumferentially on or near theouter surface of the body member, each transducer emitting signals awayfrom the respective transducer and receiving reflected signal, eachtransducer passing received signal to the proximal end of the bodymember, each array of transducers spaced along the body member from anadjacent array of transducers, wherein the transducers produce a signal;and a computer connected to the medical device to process signals fromthe medical device; calculating the distance from each transducer to thetissue or structure opposed to the transducer; producing a map of thedistances calculated from each transducer to the tissue or structureopposed to the transducer.
 20. The method of claim 19 further comprisingthe step of calculating the cross-sectional area of the area of spacearound the medical device defined by the tissue or structure opposed toeach transducer.